BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stent Graft, Bypass, Superficial Femoral Artery

    PMA: P220021 · Decision Jun 7, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Stent Graft, Bypass, Superficial Femoral Artery
    Trade Name
    DETOUR System
    PMA Number
    P220021
    Device Class
    FDA Class 3
    Product Code
    QWM
    Generic Name
    Stent graft, bypass, superficial femoral artery
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 7, 2023
    Date Received
    October 11, 2022
    Expedited Review
    N
    Docket Number
    23M-2414

    Advisory Committee Statement

    Approval for the DETOUR System for use for percutaneous revascularization in patients with symptomatic femoropopliteal lesions from 200 mm to 460 mm in length with chronic total occlusions (100 mm to 425 mm) or diffuse stenosis >70% who may be considered suboptimal candidates for surgical or alternative endovascular treatments. The DETOUR System, or any of its components, is not for use in the coronary and cerebral vasculature.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QWM Stent Graft, Bypass, Superficial Femoral Artery